Oracle Argus Safety English User's Guide Release 8.1.1

232 Pages·2017·8.01 MB·English

by  Oracle Corporation

Oracle® Argus Safety
[1]
User's Guide
Release 8.1.1
E87484-01
September 2017
Oracle Argus Safety User’s Guide, Release 8.1.1
E87484-01
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Contents
Contents iii
Preface............................................................................................................................................................... xiii
1 Updated Documentation
2 Getting Started
2.1 Logging In and Out.................................................................................................................... 2-1
2.2 Personal Argus Status................................................................................................................ 2-1
2.3 Quick Launch Toolbar................................................................................................................ 2-2
2.4 Basic Features and User Actions............................................................................................... 2-4
2.4.1 Field Validations.................................................................................................................. 2-4
2.4.2 Field-Level Help................................................................................................................... 2-5
2.4.3 Changing Your Password................................................................................................... 2-5
2.4.4 Entering Dates...................................................................................................................... 2-5
2.4.5 Using Null Flavor Data....................................................................................................... 2-6
2.4.6 Entering Multiple Language Text..................................................................................... 2-6
2.5 Integrating with Argus Insight................................................................................................. 2-7
3 Worklist
3.1 Worklist Options......................................................................................................................... 3-2
3.1.1 New and Open..................................................................................................................... 3-2
3.1.1.1 Filtering Functions—Field Descriptions................................................................... 3-3
3.1.1.2 Total Number of Rows—Field Descriptions............................................................ 3-3
3.1.2 Action Items.......................................................................................................................... 3-4
3.1.2.1 Query Action Items...................................................................................................... 3-5
3.1.2.2 Filter Function—Field Descriptions........................................................................... 3-6
3.1.3 Coding Action Items........................................................................................................... 3-6
3.1.4 Contacts................................................................................................................................. 3-6
3.1.4.1 Total Number of Rows—Field Descriptions............................................................ 3-6
3.1.5 Reports................................................................................................................................... 3-6
3.1.5.1 Filtering Options—Descriptions................................................................................ 3-7
3.1.5.2 Total Number of Rows—Field Descriptions............................................................ 3-7
3.1.6 Bulk Transmit....................................................................................................................... 3-8
3.1.6.1 Total Number of Rows—Field Descriptions............................................................ 3-8
iii
3.1.6.2 User Options—Field Descriptions............................................................................. 3-9
3.1.6.3 Routing Details............................................................................................................. 3-9
3.1.7 Bulk Print.............................................................................................................................. 3-9
3.1.7.1 Bulk Print User Options—Field Descriptions.......................................................... 3-9
3.1.8 Bulk ICSR Transmit.......................................................................................................... 3-10
3.1.8.1 Reports Tab................................................................................................................. 3-10
3.1.8.2 Total Number of Rows Section—Field Descriptions............................................ 3-11
3.1.8.3 Reports Tab User Options—Field Descriptions.................................................... 3-11
3.1.8.4 Messages Tab............................................................................................................. 3-12
3.1.8.5 Search Criteria Section—Field Descriptions.......................................................... 3-12
3.1.8.6 Total Number of Rows Section—Field Descriptions............................................ 3-13
3.1.8.7 Message Tab User Options—Field Descriptions.................................................. 3-13
3.1.9 Local Labeling................................................................................................................... 3-14
3.1.10 Coding Status.................................................................................................................... 3-14
3.1.10.1 Coding Status Icons................................................................................................... 3-15
3.1.10.2 Search Conditions Section—Field Descriptions.................................................... 3-15
3.1.10.3 Total Number of Rows Section—Field Descriptions............................................ 3-15
3.1.11 Letters................................................................................................................................. 3-16
3.1.11.1 Search Case Section—Field Descriptions............................................................... 3-16
3.1.12 Intake.................................................................................................................................. 3-16
3.1.12.1 Pending Tab—Field Descriptions........................................................................... 3-16
3.1.12.2 Rejected Tab—Field Descriptions........................................................................... 3-17
4 Case Actions
4.1 Finding and Opening Existing Cases....................................................................................... 4-1
4.1.1 Case Open Form—Fields Descriptions............................................................................. 4-1
4.1.2 Total Number of Rows—Descriptions............................................................................. 4-2
4.2 Creating a New Case.................................................................................................................. 4-2
4.2.1 Booking in Cases and Entering Initial Case Information............................................... 4-2
4.2.2 Initial Case Entry—Fields Descriptions............................................................................ 4-3
4.2.3 Checking for Duplicates..................................................................................................... 4-4
4.2.3.1 Receipt Range—Fields Descriptions.......................................................................... 4-5
4.3 Closing a Case............................................................................................................................. 4-5
4.4 Saving a Case............................................................................................................................... 4-5
4.5 Copying a Case............................................................................................................................ 4-6
4.6 Using the Medical Review Function........................................................................................ 4-6
4.6.1 Using the Medical Review Tab.......................................................................................... 4-6
4.6.1.1 The Case Narrative Section......................................................................................... 4-7
4.6.1.2 The Case Assessment Section..................................................................................... 4-7
4.6.1.3 The Event Assessment Section—Fields Descriptions.............................................. 4-7
4.6.2 Using the Temporal View Tab........................................................................................... 4-9
4.6.2.1 The Summary Section—Fields Descriptions............................................................ 4-9
4.6.2.1.1 The Display Options Section—Fields Descriptions.......................................... 4-9
4.6.2.1.2 The Event Assessment Section—Fields Descriptions...................................... 4-9
4.6.2.2 The Relevant Tests Section—Fields Descriptions................................................. 4-10
4.6.3 Using the Action Items/Additional Info Tab............................................................... 4-10
4.6.3.1 The Contact Log Section........................................................................................... 4-10
iv
4.6.3.1.1 Generating Letters.............................................................................................. 4-10
4.6.3.1.2 Scheduling Action Items for Letters................................................................ 4-11
4.6.3.2 The Action Items Section—Fields Descriptions.................................................... 4-11
4.6.3.3 The Notes and Attachments Section....................................................................... 4-11
4.7 Using the Coding Review Function...................................................................................... 4-12
4.7.1 The Coding Tab................................................................................................................. 4-12
4.7.1.1 General Information—Fields Descriptions............................................................ 4-12
4.7.1.2 Product Information—Fields Descriptions............................................................ 4-12
4.7.1.3 Event Information—Fields Descriptions................................................................ 4-12
4.7.1.4 Death Information—Fields Descriptions............................................................... 4-13
4.7.1.5 Patient Information—Fields Descriptions............................................................. 4-13
4.7.1.6 Lab Data—Fields Descriptions................................................................................ 4-13
4.7.1.7 Parent Information—Fields Descriptions.............................................................. 4-13
4.7.1.8 Case Analysis—Fields Descriptions....................................................................... 4-13
4.8 Using the Action Item Tab...................................................................................................... 4-14
4.8.1 Action Item—Fields Descriptions.................................................................................. 4-14
4.9 Using the Print Function......................................................................................................... 4-14
4.9.1 Printing a Case Form........................................................................................................ 4-14
4.9.1.1 Viewing and Printing Letters................................................................................... 4-15
4.9.1.2 Viewing and Printing Attachments........................................................................ 4-15
4.9.1.3 Transmitting a Case................................................................................................... 4-15
4.9.2 Printing a Medical Summary.......................................................................................... 4-15
4.10 Deleting a Case......................................................................................................................... 4-15
4.11 Viewing Case Revisions.......................................................................................................... 4-16
5 Case Form
5.1 Case Form Features.................................................................................................................... 5-1
5.1.1 Initial Case Entry—BookIn Dialog Box............................................................................ 5-1
5.1.2 Argus Safety Case Form User Preferences....................................................................... 5-2
5.2 General Tab.................................................................................................................................. 5-2
5.2.1 Dynamic Workflow Indicators.......................................................................................... 5-2
5.2.2 General Information............................................................................................................ 5-3
5.2.2.1 General Information—Field Descriptions................................................................. 5-3
5.2.3 Study Information............................................................................................................... 5-4
5.2.3.1 Study Information—Field Descriptions.................................................................... 5-5
5.2.4 Reporter Information.......................................................................................................... 5-5
5.2.4.1 Adding Reporter Information..................................................................................... 5-5
5.2.4.2 Reporter Information—Field Descriptions............................................................... 5-6
5.2.5 Literature Information Section........................................................................................... 5-7
5.3 Patient Tab................................................................................................................................... 5-7
5.3.1 Patient Information.............................................................................................................. 5-7
5.3.1.1 Entering Current Medical Status................................................................................ 5-7
5.3.1.2 Copying Patient Information from Reporter Information...................................... 5-7
5.3.1.3 Patient Information—Field Descriptions.................................................................. 5-7
5.3.2 Patient Details...................................................................................................................... 5-8
5.3.2.1 Entering Pregnancy Information................................................................................ 5-9
5.3.3 Event Death Details............................................................................................................. 5-9
v
5.3.3.1 Event Death Details—Field Descriptions.................................................................. 5-9
5.3.4 Other Relevant History.................................................................................................... 5-10
5.3.4.1 Other Relevant History—Field Descriptions......................................................... 5-10
5.3.5 Lab Data............................................................................................................................. 5-11
5.3.5.1 Lab Data—Field Descriptions.................................................................................. 5-12
5.3.6 Relevant Tests.................................................................................................................... 5-12
5.3.7 Parent Information........................................................................................................... 5-12
5.4 Products Tab............................................................................................................................. 5-12
5.4.1 Searching for Products..................................................................................................... 5-13
5.4.2 Time Measurement Fields............................................................................................... 5-14
5.4.3 Drug Tab............................................................................................................................ 5-15
5.4.3.1 Product Information—Field Descriptions............................................................. 5-15
5.4.3.2 The Product Indication ............................................................................................ 5-16
5.4.3.3 Entering Quality Control Information.................................................................... 5-17
5.4.3.4 Dosage Regimens—Field Descriptions.................................................................. 5-17
5.4.3.5 Product Details—Field Descriptions...................................................................... 5-18
5.4.3.6 Study Drug Information........................................................................................... 5-19
5.4.4 The Device Tab.................................................................................................................. 5-19
5.4.4.1 Product Information—Field Descriptions............................................................. 5-20
5.4.4.2 Entering Quality Control Information.................................................................... 5-21
5.4.4.3 Product Indication..................................................................................................... 5-22
5.4.4.4 Product Delivered by Device—Field Descriptions............................................... 5-22
5.4.4.5 Device Component Information—Field Descriptions......................................... 5-22
5.4.4.6 Device Information—Field Descriptions............................................................... 5-22
5.4.5 Vaccine Tab........................................................................................................................ 5-24
5.4.5.1 Product Details........................................................................................................... 5-24
5.4.5.2 Prior Adverse Events Information......................................................................... 5-24
5.4.5.3 Product Information Section—Field Descriptions............................................... 5-24
5.4.5.4 Vaccine Administration Form—Field Descriptions ........................................... 5-25
5.4.5.5 Vaccine History Section—Field Descriptions........................................................ 5-26
5.5 Events Tab................................................................................................................................. 5-26
5.5.1 Event Tab........................................................................................................................... 5-27
5.5.1.1 Event Information Section........................................................................................ 5-27
5.5.1.1.1 Understanding the Diagnosis-Event Relationship........................................ 5-28
5.5.1.1.2 Associating a symptom with a diagnosis....................................................... 5-28
5.5.1.1.3 Using the MedDRA Browser............................................................................ 5-29
5.5.1.1.4 Configuring Regulatory Reporting Rules....................................................... 5-29
5.5.2 Event Coding Section....................................................................................................... 5-29
5.5.3 Seriousness Criteria Section............................................................................................ 5-30
5.5.3.1 Entering Death Details.............................................................................................. 5-30
5.5.3.2 Entering Hospitalization Details............................................................................. 5-30
5.5.3.3 Nature of Event Section............................................................................................ 5-31
5.5.3.4 Details Section............................................................................................................ 5-31
5.5.4 Event Assessment Tab..................................................................................................... 5-31
5.5.4.1 Event Assessment Tab—User Actions................................................................... 5-31
5.5.4.2 Event Assessment Tab—Filtering........................................................................... 5-32
5.5.4.3 Product-Event Details Tab....................................................................................... 5-32
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5.6 Analysis Tab............................................................................................................................. 5-33
5.6.1 Analysis Tab...................................................................................................................... 5-33
5.6.1.1 Case Analysis Section............................................................................................... 5-33
5.6.1.2 Case Summary Section............................................................................................. 5-34
5.6.2 The MedWatch Info Tab.................................................................................................. 5-35
5.6.2.1 Selecting G3 Report Source Checkboxes—Guidelines......................................... 5-36
5.6.3 The BfArM Info Tab......................................................................................................... 5-37
5.6.4 The AFSSaPS Info Tab...................................................................................................... 5-37
5.7 Activities Tab............................................................................................................................ 5-38
5.7.1 Contact Log Section.......................................................................................................... 5-38
5.7.1.1 Generating Letters..................................................................................................... 5-39
5.7.1.2 Scheduling Action Items for Letters....................................................................... 5-40
5.7.1.3 Opening a Message Editor....................................................................................... 5-40
5.7.2 Action Items Section......................................................................................................... 5-40
5.7.3 Routing Comments Section............................................................................................. 5-41
5.7.3.1 Routing Cases............................................................................................................. 5-41
5.7.3.2 Returning Cases......................................................................................................... 5-42
5.7.4 Case Lock/Close Section................................................................................................. 5-43
5.7.4.1 Locking a Case........................................................................................................... 5-45
5.7.4.2 Unlocking a Case....................................................................................................... 5-45
5.7.4.3 Setting the Focus for a Follow-up Event................................................................ 5-47
5.8 Additional Information Tab................................................................................................... 5-47
5.8.1 Searching for Documentum Links................................................................................. 5-49
5.8.2 Attaching Files to a Case.................................................................................................. 5-49
5.8.2.1 To attach files to a case.............................................................................................. 5-49
5.8.3 Entering Keywords........................................................................................................... 5-49
5.8.4 Attaching References to a Case....................................................................................... 5-49
5.9 Regulatory Reports Tab.......................................................................................................... 5-49
5.9.1 Grouping Regulatory Reports........................................................................................ 5-51
5.9.1.1 Grouping by Report Type/Submit Category/Reporting Destination.............. 5-52
5.9.1.2 Grouping by Report Type/Reporting Destination............................................... 5-52
5.9.1.3 Grouping by Report Type/Reporting Group....................................................... 5-52
6 Reports: Compliance and Aggregate Reports
6.1 Reports.......................................................................................................................................... 6-1
6.1.1 Compliance Reports............................................................................................................ 6-1
6.1.1.1 About Expedited Reports............................................................................................ 6-1
6.1.1.1.1 Storing Expedited Reports in Documentum..................................................... 6-2
6.1.1.1.2 Understanding Follow-up Reports..................................................................... 6-2
6.1.1.1.3 Viewing a Summary of Expedited Regulatory Reports.................................. 6-3
6.1.1.1.4 User Options.......................................................................................................... 6-3
6.1.1.1.5 Scheduling Reports............................................................................................... 6-4
6.1.1.1.6 Generating Reports............................................................................................... 6-5
6.1.1.1.7 Approving Reports............................................................................................... 6-6
6.1.1.1.8 Creating Unscheduled Expedited Reports........................................................ 6-6
6.1.1.1.9 Creating Batch Reports......................................................................................... 6-8
6.1.1.1.10 Expedited Reporting Rules Algorithm............................................................... 6-9
vii
6.1.1.2 About Periodic Reports............................................................................................ 6-10
6.1.1.2.1 Periodic Report—Fields and Field Descriptions............................................ 6-11
6.1.1.2.2 User Options....................................................................................................... 6-11
6.1.1.2.3 About the Report Details dialog box............................................................... 6-11
6.1.1.2.4 Scheduling Tab................................................................................................... 6-11
6.1.1.2.5 Routing Tab......................................................................................................... 6-12
6.1.1.2.6 Submission Tab................................................................................................... 6-12
6.1.1.2.7 Comment Tab...................................................................................................... 6-12
6.1.1.2.8 Report Generation Status ................................................................................. 6-12
6.1.1.3 Creating Unscheduled Periodic Reports................................................................ 6-14
6.1.1.4 About Submitted Reports......................................................................................... 6-14
6.1.1.4.1 Submitting Reports............................................................................................ 6-14
6.1.1.4.2 Submitted Reports Search Results—Fields and Field Descriptions............ 6-15
6.1.1.4.3 Unsubmitting Reports....................................................................................... 6-16
6.1.1.4.4 Lock State Header Options............................................................................... 6-16
6.1.2 Aggregate Reports............................................................................................................ 6-16
6.1.2.1 Using the System Reports Library.......................................................................... 6-17
6.1.2.2 About Case Data Analysis Reports......................................................................... 6-18
6.1.2.2.1 Creating a Case Data Analysis Report............................................................ 6-18
6.1.2.3 About CIOMS II Line Listing Reports.................................................................... 6-20
6.1.2.3.1 Creating a CIOMS II Line Listing Report....................................................... 6-20
6.1.2.4 About Case Listing Reports..................................................................................... 6-21
6.1.2.5 Checking the Aggregate Report Status.................................................................. 6-21
7 Reports: Periodic Reports
7.1 Periodic Report Types................................................................................................................ 7-1
7.1.1 Categorize Cases in Periodic Reports............................................................................... 7-1
7.1.2 Store Periodic Reports in Documentum........................................................................... 7-1
7.1.3 View a Summary of Periodic Regulatory Reports.......................................................... 7-1
7.1.4 Use the Library Page........................................................................................................... 7-2
7.1.5 Create Clinical Trial Periodic Reports.............................................................................. 7-2
7.1.5.1 Common Tab Fields—Field Descriptions................................................................. 7-2
7.1.5.1.1 Subject of Report Tab—Fields Descriptions...................................................... 7-3
7.1.5.1.2 Product Selection Tab—Fields Descriptions..................................................... 7-4
7.1.5.1.3 License/Study Tab—Fields Descriptions.......................................................... 7-5
7.1.5.1.4 Inclusion Criteria Tab—Fields Descriptions..................................................... 7-5
7.1.5.1.5 Using the DLP Version......................................................................................... 7-7
7.1.5.1.6 Dates for Using DLP/As of reporting Function.................................................. 7-7
7.1.5.1.7 As of Reporting Function..................................................................................... 7-7
7.1.5.1.8 Availability of DLP/As of query functionality................................................. 7-7
7.1.5.1.9 Line Listing Tab—Fields Descriptions............................................................... 7-8
7.1.5.1.10 Available Data Elements...................................................................................... 7-8
7.1.5.1.11 Selected Data Elements......................................................................................... 7-8
7.1.5.1.12 Grouping Tab—Fields Descriptions................................................................... 7-9
7.1.5.1.13 Summary Tabulations Tab—Fields Descriptions............................................. 7-9
7.1.5.1.14 Single Case Submission Support—Fields Descriptions................................ 7-12
7.1.5.1.15 UD Summaries Tab—Fields Descriptions...................................................... 7-13
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7.1.5.1.16 Scheduling Tab—Fields Descriptions............................................................. 7-13
7.1.5.1.17 Scheduling Frequency—Fields Descriptions................................................. 7-14
7.1.5.1.18 Security Tab—Fields Descriptions................................................................... 7-14
7.1.6 About ICH PSUR Reports............................................................................................... 7-14
7.1.6.1 Common Tab Fields—Fields Descriptions............................................................ 7-15
7.1.6.1.1 Subject of Report Tab—Fields Descriptions................................................... 7-16
7.1.6.1.2 Product Selection Tab—Fields Descriptions.................................................. 7-17
7.1.6.1.3 Inclusion Criteria Tab—Fields Descriptions.................................................. 7-17
7.1.6.1.4 Inclusion Criteria—Fields Descriptions.......................................................... 7-18
7.1.6.1.5 Line Listing Tab—Fields Descriptions............................................................ 7-19
7.1.6.1.6 Available Data Elements................................................................................... 7-19
7.1.6.1.7 Selected Data Elements—Fields Descriptions................................................ 7-19
7.1.6.1.8 Grouping Tab—Fields Descriptions................................................................ 7-20
7.1.6.1.9 Summary Tabulations Tab................................................................................ 7-21
7.1.6.2 CIOMS Reports—Fields Descriptions.................................................................... 7-22
7.1.6.2.1 PBRER Section 6.2 - Cumulative Summary Tabulations of SAEs from clinical
trials 7-22
7.1.6.2.2 PBRER Section 6.3 - Cumulative and Interval Summary Tabulations from
Post-Marketing Data Sources 7-22
7.1.6.2.3 Cumulative Summary—Fields Descriptions.................................................. 7-23
7.1.6.2.4 FDA PSUR Support—Fields Descriptions...................................................... 7-23
7.1.6.2.5 Single Case Submission Support—Fields Descriptions................................ 7-24
7.1.6.2.6 UD Summaries Tab—Fields Descriptions...................................................... 7-25
7.1.6.2.7 Scheduling Tab—Fields Descriptions............................................................. 7-25
7.1.6.2.8 Scheduling Frequency—Fields Descriptions................................................. 7-26
7.1.6.2.9 Security Tab......................................................................................................... 7-26
7.1.6.2.10 Templates Tab..................................................................................................... 7-26
7.1.7 About US IND Periodic Reports..................................................................................... 7-26
7.1.7.1 Common Fields—Fields Descriptions.................................................................... 7-27
7.1.7.1.1 Subject of Report Tab—Fields Descriptions................................................... 7-27
7.1.7.1.2 Product Selection Tab—Fields Descriptions.................................................. 7-29
7.1.7.1.3 Inclusion Criteria Tab—Fields Descriptions.................................................. 7-29
7.1.7.1.4 Line Listing Tab—Fields Descriptions............................................................ 7-30
7.1.7.1.5 Summary Tabulations Tab—Fields Descriptions.......................................... 7-30
7.1.7.1.6 Scheduling Tab—Fields Descriptions............................................................. 7-31
7.1.7.1.7 Security Tab—Fields Descriptions................................................................... 7-31
7.1.8 About NDA Periodic Reports......................................................................................... 7-32
7.1.8.1 Common Fields—Fields Descriptions.................................................................... 7-33
7.1.8.2 Subject of Report Tab—Fields Descriptions.......................................................... 7-33
7.1.8.3 Product Selection Tab—Fields Descriptions.......................................................... 7-35
7.1.8.4 Inclusion Criteria Tab—Fields Descriptions.......................................................... 7-36
7.1.8.5 Line Listing Tab—Fields Descriptions................................................................... 7-36
7.1.8.6 Summary Tabulations Tab—Fields Descriptions................................................. 7-38
7.1.8.7 Scheduling Tab—Fields Descriptions..................................................................... 7-38
7.1.8.7.1 Scheduling Frequency....................................................................................... 7-39
7.1.8.8 Security Tab—Fields Descriptions.......................................................................... 7-39
7.1.9 Bulk Reporting................................................................................................................. 7-39
ix
7.1.9.1 Bulk Reporting Filter Section—Fields Descriptions............................................. 7-39
7.1.9.2 Total Number of Rows Section—Fields Descriptions.......................................... 7-40
7.1.9.3 Printing Options—Fields Descriptions.................................................................. 7-40
7.1.9.4 User Options............................................................................................................... 7-41
7.1.9.4.1 Lock State Header Options............................................................................... 7-41
7.1.9.4.2 Lock State Icon Options—Fields Descriptions............................................... 7-41
7.1.10 Initial and Follow-up Cases in Periodic Reports.......................................................... 7-41
8 Reports: Bulk Reporting, ICSR Pending, and Processed ICSR Reports
8.1 Bulk Reporting............................................................................................................................ 8-1
8.1.1 Bulk Report—Filter Options.............................................................................................. 8-1
8.1.2 Viewing Bulk Reporting Search Results........................................................................... 8-2
8.1.3 Printing Options................................................................................................................... 8-3
8.1.4 Lock State User Options..................................................................................................... 8-3
8.2 ICSR Pending Reports................................................................................................................ 8-3
8.2.1 Incoming ICSR Reports—Fields Description.................................................................. 8-4
8.2.1.1 Button and Right-click Options.................................................................................. 8-5
8.2.2 Pending Reports................................................................................................................... 8-5
8.2.3 Bulk Incoming ICSR Reports............................................................................................. 8-5
8.2.4 Duplicate Search.................................................................................................................. 8-6
8.2.4.1 Duplicate Search Dialog Box—Field Description.................................................... 8-7
8.2.4.2 Duplicate Search for Incoming Review..................................................................... 8-7
8.2.5 View Differences Report..................................................................................................... 8-8
8.2.5.1 Accept Initial E2B Cases As Follow-Up.................................................................... 8-9
8.3 Processed ICSR Reports............................................................................................................. 8-9
8.3.1 Search Criteria Section—Field Description...................................................................... 8-9
8.3.2 Viewing Search Results.................................................................................................... 8-10
9 Local Lock Functionality
9.1 Enabling Local Data Entry......................................................................................................... 9-1
9.1.1 Local Fields........................................................................................................................... 9-1
9.2 References for Details on Local Case Data Lock Functionality............................................ 9-2
9.3 Report Scheduling - Auto-Scheduling..................................................................................... 9-4
9.4 Report Scheduling - Manual Scheduling................................................................................. 9-5
9.5 Outlier Processing....................................................................................................................... 9-5
9.6 Upgrade Changes - Enabling Local Locking in Argus Safety.............................................. 9-6
9.7 Triggering Local Reports - Report Generation Algorithm.................................................... 9-7
10 Utilities
10.1 Change Password.................................................................................................................... 10-1
10.2 MedDRA Browser.................................................................................................................... 10-1
10.3 User Login List......................................................................................................................... 10-1
10.4 Logs............................................................................................................................................ 10-2
10.4.1 View Audit Log................................................................................................................. 10-2
10.4.1.1 Audit Log Details Screen.......................................................................................... 10-2
10.4.2 LAM Audit Log................................................................................................................. 10-3
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